EMEA-000830-PIP02-10-M02

Key facts

Invented name
Gammaplex
Active substance
Human normal immunoglobulin
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0295/2015
PIP number
EMEA-000830-PIP02-10-M02
Pharmaceutical form(s)
Solution for infusion
Condition(s) / indication(s)
  • Treatment of idiopathic thrombocytopenic purpura as a model for immunomodulation
  • Treatment of primary immunodeficiency (PID) as model for replacement therapy
Route(s) of administration
Intravenous use
Contact for public enquiries
Bio Products Laboratory Limited
United Kingdom
Tel. +44 (0)20 8957 2622
Fax +44 (0)20 8957 2608
E-mail: Omotayo.Onabaworin@bpl.co.uk
 
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000830-PIP02-10-M02
Compliance opinion date
29/01/2016
Compliance outcome
positive

Decision

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